Virtual Far-sight Reading Device for Myopia Intervention Among Pre-myopic Children

NCT06995911 | Recruiting DMC

• 1 other identifier: YMZSSJLY202501
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial wants to find out if the Virtual Far-sight Reading Device can help prevent or slow down myopia progression in children and teenagers with pre-myopia. We also want to know what makes this treatment work better for some participants and check for any eye or body-related side effects over time. Main questions: Can using the Virtual Far-sight Reading Device reduce the risk of myopia? Is the device safe to use every day for up to 6 months? What we'll do: Researchers will compare two groups of children: Group A: Uses the device for reading/writing (at least 1 hour daily) Group B: Does regular reading/writing without the device After 90 days, the groups will switch to see if the results stay the same. Participants will:

• Have free eye checkups 3 times over 6 months
• Use the device during homework time (if in the desk group)
• Report any eye discomfort or problems

Conditions

Myopia; Pre-myopia

Keywords

Myopia; Pre-myopia

Outcome Measures

Primary Outcomes (1)

• Changes in Spherical Equivalent Refraction

  90 and 180 days from baseline

Secondary Outcomes (2)

• Changes in Axial Length

  90 and 180 days from baseline

• Cumulative Incidence of Myopia

  90 and 180 days from baseline

Other Outcomes (9)

• Changes in Accommodative Response

  90 and 180 days from baseline

• Changes in Facility of Accommodation

  90 and 180 days from baseline

• Changes in Positive/Negative Relative Accommodation

  90 and 180 days from baseline

Study Arms (2)

Nearwork with the Virtual Far-sight Reading Device

EXPERIMENTAL

Device: Virtual Far-sight Reading Device

Nearwork without the Virtual Far-sight Reading Device

NO INTERVENTION

Interventions

Virtual Far-sight Reading Device DEVICE

The Virtual Far-sight Reading Device utilizes a birdbath optical configuration and freeform surface technology to extend the working distance from 30 cm to over 6 meters, thereby simulating distance viewing conditions and maintaining ciliary muscle relaxation. Study participants were required to engage in reading and writing tasks using the device for a cumulative daily duration of at least 1 hour.

Nearwork with the Virtual Far-sight Reading Device

Eligibility Criteria

• Age: 6 Years - 12 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: 6-12 years (inclusive), gender unrestricted.
• Worse eye cycloplegic spherical equivalent refraction (SER): -0.5 D \< SER ≤ +0.75 D; Cylinder ≤ -1.5 D in both eyes; Interocular anisometropia ≤ 1.5 D ③ Visual acuity: Best-corrected visual acuity (BCVA) ≤ 0.1 logMAR in both eyes. ④ Family history: At least one parent with myopia.
• Intraocular pressure (IOP): 10-21 mmHg in both eyes; Interocular IOP difference ≤ 5 mmHg
• ⑥ Compliance: Commitment to daily home use of the Far-Image Light Field Desk per protocol, immediate notification to investigators if unable to comply, and completion of scheduled follow-ups.
• ⑦ Informed consent: Signed assent form (minor) and written informed consent from legal guardian.

You may not qualify if:

• Ocular comorbidities affecting vision/refractive development: Marfan syndrome; Lens pathologies (e.g., cataracts); Glaucoma; retinal detachment; retinopathy of prematurity
• Systemic diseases: Immune/CNS disorders; Down syndrome; Severe cardiopulmonary/hepatic/renal dysfunction; Uncontrolled asthma
• Ocular abnormalities: Manifest strabismus; Binocular vision dysfunction; Pathological ocular changes or active ocular inflammation ④ Recent myopia interventions (within 3 months prior to screening): Orthokeratology; multifocal contact lenses; Functional spectacles, red-light therapy
• ⑤ Medications affecting efficacy evaluation (within 3 months): Anticholinergics (e.g., atropine, pirenzepine); Cholinergics (e.g., pilocarpine)
• ⑥ Participation in other clinical trials within 3 months.
• ⑦ Contraindications/allergies to cycloplegics or study-related medications.
• ⑧ Chronic psychiatric disorders or cognitive impairment.
• ⑨ Other conditions deemed unsuitable by investigators.

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead

Study Sites (1)

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Wei Xu, Prof

CONTACT

+86 18521513008; vvxuwei@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This randomized controlled crossover trial was conducted in two sequential phases: Phase I (Day 0-90): Group A: Performed daily near-work activities (e.g., reading/writing) using the Virtual Far-sight Reading Device with cumulative daily use ≥60 minutes. Group B: Engaged in routine near-work activities without intervention. Phase II (Day 90-180): Group A: Switched to standard near-work practice without device use. Group B: Initiated Virtual Far-sight Reading Device intervention under identical protocol (≥60 min/day cumulative use).

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: June 1, 2025
• Primary Completion: May 31, 2026
• Study Completion: May 31, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Locations

CN (1)